FMEA may Effectively Identify and Mitigate Risks in ZAP-X Radiosurgery System Implementation, reveals Study

The study published online in Apollo Medicine highlighted that the FMEA approach identified a wide range of risks, from operational challenges with the equipment to issues in patient treatment, showcasing the complexities of integrating new technologies into the healthcare system.

The ZAP-X Gyroscopic Radiosurgery System is a safe, efficient, and precise technology for non-invasive stereotactic radiosurgery (SRS) in brain and neck conditions like tumors, lesions, and neurological conditions, minimizing radiation exposure while protecting healthy tissues.

As clinical equipment and processes become more complex, the risk of failures increases. Predicting these failures helps prevent or reduce their impact using available risk management tools. One useful management tool is Failure Mode and Effect Analysis (FMEA), which helps identify, assess, and prioritise the impact and likelihood of potential failures.

To address the risk associated with the ZAP-X Radiosurgery System using the FMEA approach, researchers Dr. Libin K. Babu, Quality Department, Indraprastha Apollo Hospitals, New Delhi, Delhi, India and the team conducted a study where they mapped all processes and sub-processes associated with the ZAP-X Radiosurgery System implementation. The team identified failure modes through discussions on potential issues, prioritized risks using Risk Priority Numbers (RPN) based on severity, likelihood, and detectability, and proposed controls to improve safety and reliability.

The key findings of the study are:

1)Overall findings:

i)A total of 78 failure modes were identified across 6 processes and 33 sub-processes

ii)RPNs ranged from 48 (highest) to 1 (lowest)

2)Process: Equipment –

i)FMEA identified the highest RPN (48) in the operational handover sub-process due to inadequate staff training.

ii)The lowest RPNs (2) were seen in installation and calibration, where risks like instability were mitigated by trained teams and tested protocols.

3) Process: Infection Control- Had an average RPN of 8 across two sub-processes, indicating moderate risks, both effectively managed by existing controls:

i) Proper protocols not followed for infected patients.

ii) Risk of hospital-associated infections

4) Process: Fire Safety - It includes five sub-processes. The highest RPN (36) was linked to fire suppression system failure due to the lack of a system suited for ZAP-X equipment. The lowest RPN (6) involved fire hazards from patients wearing oxygen masks caused by untrained staff and missing protocols, which was mitigated by stopping oxygen supply and staff training.

5) Process: Security

i) RPNs (4, 8): Risks included unauthorized access, cyber threats, and system misuse.

ii) Mitigated by safety interlocks, limited access, encryption, and warning notifications.

6) Process: Radiation Safety

i) Highest RPN (32): Machine non-compliance with regulatory standards.

ii) Lowest RPN (1): Radiation exposure to attendants mitigated by restricted access and self-shielding machine design.

7) Process: Patient Treatment-

i) Average RPN (6): Moderate risks identified, such as excess dose delivery and incorrect alignment.

ii) Control Measures:

• Emergency stop (E-Stop) for beam deviations.

• Real-time patient monitoring and dose verification.

• High voltage enabled only with safety controls.

• Regular maintenance checks ensure optimal performance.

Mentioning the significant implications of the study Dr Libin K. Babu, the lead author of the study told medical dialogues, “Using ZAP -X means a safer setting with less dangers for both patients and staff when using the equipment and receiving treatment. By lowering errors and preventing downtime, it increases operational efficiency for hospitals. Globally, it provides a useful foundation that other Healthcare institutions can use to safely implement innovative technologies like ZAP-X. It serves as a guide for incorporating innovation without sacrificing dependability or safety.”

The lead author also addressed the limitations and Future Research associated with the study, he said, “We focused on the implementation at a single hospital, so while the findings are comprehensive, they might not apply universally to other institutions with different workflows or resources. Additionally, our study anticipates risks, but there’s always a possibility of unforeseen challenges in real-world use. I think further multicenter studies are needed in the future to confirm our findings in other clinical contexts.”

Reference: Babu LK, Kumar S, Nayak Y, Malani A. Risk Assessment of ZAP-X→ Radiosurgery System in a Quaternary Care Hospital Using FMEA Approach. Apollo Medicine. 2024;0(0). doi:10.1177/09760016241278899